The Food and Drug Administration (FDA) continues to wage a protracted war against Kratom, and over the years tremendous amounts of Kratom has been seized, causing big losses for Kratom vendors and leading to higher prices and less variety for Kratom users. Further, Kratom has been banned in several states and municipalities, depriving millions of Americans of the only safe alternative to synthetic opioids and opiates, and this has undoubtedly destroyed countless lives that could have been saved by Kratom. Even worse, the FDA is persistently threatening to get Kratom banned on a Federal level, which would cause a national catastrophe.
There is one wild card that could free the Kratom industry from the FDA’s clutches. If anyone can prove that Kratom was marketed for human consumption before October 15 1994, then Kratom would no longer require approval from the FDA, since it would be considered a pre-DSHEA grandfathered supplement.
Essentially, the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, and it completely changed the regulatory landscape for supplements. Ultimately the FDA was given more power and control, and any new supplement needed to apply as a new dietary ingredient (NDI) and be accepted by the FDA in order to be sold in the United States.
However, DSHEA included a clause where any supplement which was marketed for human consumption in the United States before October 15 1994 is basically grandfathered in, and does not have to submit an NDI application nor be approved by the FDA.
Indeed, this is the reason that Kava is not being attacked by the FDA, since it has been proven that Kava was marketed for human consumption in the United States before 1994. Literally, Kava would face just as much FDA scrutiny as Kratom, and would potentially be banned, if Kava was not a pre-DSHEA dietary ingredient.
Further, vendors of pre-DSHEA supplements like Kava are essentially free to make whatever health claims they want without being penalized by the FDA. Compare this to the Kratom industry, where if a Kratom vendor makes health claims the FDA can shutdown their entire business and seize their entire inventory, under the pretense that Kratom is an unapproved and dangerous drug.
Unfortunately, proving that Kratom was marketed for human consumption before 1994 is apparently incredibly difficult. Unlike Kava which is naturally grown in Hawaii since ancient days, Kratom does not naturally grow in the United States.
Further, the Kratom industry started due to the advent of the internet, and there was little if any Kratom industry before the launch of the World Wide Web in 1991. Indeed, the Kratom industry didn’t really kick off until years after the internet was launched, since it took some time for the internet to become popular.
Therefore, finding evidence of Kratom being sold in the United States on the internet is extremely hard. It is possible that some evidence exists deep in the Internet Archive, but I have looked for awhile with no luck so far.
That being said, the situation is not completely hopeless. A headshop owner from Florida claims that he was selling Kratom since the early 80s. Although this particular headshop owner has passed away, if any headshop was selling Kratom before 1994, then it is likely that many headshops were selling Kratom before 1994.
There is a big catch however. Even if someone proves that a headshop was selling Kratom before 1994, the Kratom has to be marketed for human consumption. Unfortunately, most vendors and headshops sold Kratom as a ‘botanical specimen’ or as ‘incense’ during the early years of the industry, making the search for evidence much harder.
Indeed, Kratom Cafe reached out to one of the most well-known Kratom advocates, and learned that hundreds of thousands of dollars has been spent trying to find proof that Kratom was sold for human consumption before 1994, and after 5 years of effort only evidence of Kratom being sold as a botanical specimen before 1994 has been found.
All of this being said, the Kratom community should not give up hope, since it is incredibly likely someone sold Kratom for human consumption in the United States before 1994, their story has simply just not been brought to light yet.
According to the FDA, an advertisement, a restaurant menu, a photo, a receipt, etc. which shows that a supplement was marketed for human consumption before 1994 are all sufficient proof to get a supplement grandfathered status. On the other hand, word of mouth and memories do not count as evidence.
There is one last big catch however. The FDA keeps no central list of pre-DSHEA supplements, and the FDA does not have a definitive process for grandfathering a supplement. Due to this, the FDA could play all sorts of legal games if someone submitted real proof that Kratom was marketed for human consumption before 1994. In-fact, the FDA could even completely ignore such evidence, and it would take a tremendous amount of time and money to force the FDA to follow the pre-DSHEA law.
In other words, the FDA would probably put up a fight and ignore the pre-DSHEA law if someone really found proof that Kratom is a pre-DSHEA supplement.
Zooming out, no matter how hard the process is for getting a substance grandfathered as pre-DSHEA, it is worth the effort since literally millions of lives would be saved in the present and the future if Kratom is successfully recognized as a pre-DSHEA supplement.
Therefore, Kratom Warriors should try to find evidence that Kratom was marketed for human consumption before 1994, since if that evidence is found it would ultimately win the entire Kratom fight.
On a final note, the pre-DSHEA law itself is overly strict to the point of absurdity. Specifically, Kratom has been used since ancient times in Southeast Asia, and therefore has been marketed for human consumption for thousands of years. Just because Kratom wasn’t marketed for human consumption in the United States before 1994 shouldn’t make the difference for Kratom’s pre-DSHEA status, if the system was based on logic and reason.